UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056672 |
|---|---|
| Receipt number | R000064773 |
| Scientific Title | Safety and tolerability trial of a home pneumatic lymphatic drainage or secondary lower limb lymphedema |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/10 09:05:49 |
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Basic information
Public title
Safety and tolerability trial of a home pneumatic lymphatic drainage for secondary lower limb lymphedema
Acronym
Safety and tolerability trial of a home pneumatic lymphatic drainage for secondary lower limb lymphedema
Scientific Title
Safety and tolerability trial of a home pneumatic lymphatic drainage or secondary lower limb lymphedema
Scientific Title:Acronym
Safety and tolerability trial of a home pneumatic lymphatic drainage for secondary lower limb lymphedema
Region
| Japan |
Condition
Condition
Secondary lower limb lymphedema
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary perpose is to investigate the safety and torelability of a home pneumatic lymphatic drainage device for seconary lower limb lymphedema
Basic objectives2
Others
Basic objectives -Others
safety and torelability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence of a home Pneumatic lymphatic drainage
Key secondary outcomes
Demographic information (age, gender, height, weight, BMI, dominant hand)
Social background (employment status, household members)
Medical information (primary disease, side of lymphedema, symptoms associated with lymphedema, medical history , drug history, ISL stage, peripheral circulatory status)
Safety and tolerability (tolerability-limiting events, adverse events, deviations, usability)
Efficacy (lower limb circumference, QOL: J-LYMQOL-l, subjective assessment)
Other (physical activity : GPAQ, adherence of compression and weight management)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
This study uses the following device, which has been approved as a medical device in Japan and is closest to clinical application
Name: Sequential Pneumatic Lymph Drainage (PLD)
LIMITI (Techno Takatsuki Co., Ltd.)
Medical device approval number: 30600BZX00129000
Implementation: Drainage therapy using the PLD, which is rented, at home.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Outpatient with secondary lower limb lymphedema
2) Experience worsening of their lymphedema in the past 3 months
3) Age: 35 and 80 years
4) Consent to participate in this study
5) ISL stage II or III
Key exclusion criteria
1) DVT, thrombophlebitis, PE, or suspected these conditions
2) Ssevere arteriosclerosis or ischemic disease in the treated area
3) CHF
4) Possible negative effect by increasing blood flow to the heart
5) Weak bones (osteoporosis, etc.), a fracture or dislocation in the treated area
6) Acute inflammatory findings (dermatitis, cellulitis, etc.), severe skin disorders, ulcers, necrosis or gangrene in the treated area
7) Weak or unstable skin in the treated area, or recent skin graft
8) Sensory disorders in the treated area
9) Acute or chronic abdominal diseases, or Recent abdominal surgery
10) Muscle strain, torn fascia or muscle fibres, sprains or tendonitis in the treated area
11) Pregnancy
12) Patients who the doctor deems unsuitable for PLD use, such as those who cannot use it properly
13) Dementia, intellectual disability or suspected these conditions
14) Communicational difficulties with medical staff and maintenance staff due to language problems, etc.
15) Patients who have difficulty working with doctors during past medical treatment
16) Incapability of attending regular check-ups according to doctor requirement
17) Inpatients
18) Participation in a other clinical trial in the past 4 months
19) Severe peripheral neuropathy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Miyake |
Organization
Kosei hospital
Division name
LYMPHEDEMA center
Zip code
700-0985
Address
3-8-35 Kosei-machi, Kita-ku, Okayama City, Okayama Prefecture
TEL
086-222-6806
velice.ltd@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Okawara |
Organization
Keio University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633812
Homepage URL
hiroki.okawara@keio.jp
Sponsor or person
Institute
Kosei hospital
Institute
Department
Personal name
Kazynasa Miyake
Funding Source
Organization
This research is conducted with the free loan of equipment from Techno Takatsuki Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kita Fukushima Medical Center
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Koseikai Medical Ethics Committee
Address
3-8-35 Kosei-machi, Kita-ku, Okayama City, Okayama Prefecture
Tel
086-222-6806
none
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
光生病院（岡山県）
北福島医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064773
